New Drug

The following is a recent approval announced by the US Food and Drug Administration (FDA):

Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) has been approved for a new indication by the FDA for patients with certain diabetic foot ulcers. Approval of the device, which can be placed over an ulcer and provides an environment for new skin and tissue to regenerate, was based on the results of a clinical trial comparing the Omnigraft device to standard diabetic foot ulcer care (eg, cleaning and covering the wound with a surgical bandage and keeping weight off of the foot with the ulcer). In the study, 51% of patients treated with Omnigraft had healed ulcers after 16 weeks, versus 32% of patients who received standard care alone.

Announcements

The FDA recently announced that a draft guidance was issued to electronic medical device manufacturers, outlining important steps they need to take to continually address cybersecurity risks, keep patients safe, and better protect public health. The guidance includes recommendations for monitoring, recognizing, and responding to cybersecurity vulnerabilities in medical devices that are on the market, and addresses the significance of sharing data through the Information Sharing and Analysis Organization.

Another FDA announcement stated that, at the agency's request, US Marshals seized approximately 90,000 bottles of RelaKzpro, which is a dietary supplement containing kratom, a botanical substance grown in Thailand that can cause symptoms such as respiratory depression, vomiting, nervousness, weight loss, and constipation. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, any dietary supplements containing kratom are considered adulterated. RelaKzpro is manufactured by Dordoniz Natural Products LLC, South Beloit, IL.

According to a press release by the FDA, a consent decree of permanent injunction has been entered between the United States and Downing Labs, LLC, Dallas, TX—including the company's co-owners and pharmacist-in-charge—by District Judge Sam A. Lindsay. Implemented by the US Department of Justice on behalf of the FDA, the consent decree prohibits Downing Labs, which manufactured and distributed purportedly adulterated drug products, from producing, holding, or distributing drugs until they comply with the FD&C Act and other requirements.

The FDA has also recently issued 2 final orders to manufacturers and the public to bolster data requirements for surgical mesh for repairing pelvic organ prolapse (POP) transvaginally. The orders entail reclassifying these devices from class 2 (eg, moderate risk) to class 3 (eg, high risk), and requiring manufacturers to submit a premarket approval application to support the safety and efficacy of surgical mesh for transvaginal POP repair.